neoadjuvant docetaxel and cisplatin plus chemoradiotherapy followed by surgery in treating patients with locally advanced, resectable esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. purpose: this phase ii trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.

objectives: primary * determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer. * determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients. secondary * determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results. * correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen. * determine the quality of life of patients treated with this regimen. * determine the clinical benefit of this regimen in these patients. outline: this is a multicenter study. * neoadjuvant chemotherapy: patients receive docetaxel iv over 1 hour and cisplatin iv over 1 hour on days 1 and 22. * chemoradiotherapy: beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel iv over 30 minutes and cisplatin iv over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks. * surgery: patients undergo surgery 3-8 weeks after the final administration of radiotherapy. treatment continues in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year. patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. projected accrual: approximately 22-66 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (siewert type i) * locally advanced disease that is technically operable with curative intent (r0) * t3, n0 or t1-3, n+ or t4, nx * no t1-2, n0 * no inoperable t4 (unequivocal organ involvement) * no distant metastasis, including m1a lymph node status * lymph nodes suspicious of m1a status by ct scan, pet scan, or ultrasound must be verified by fine-needle aspiration cytology * no carcinoma of the cervical esophagus * obstructive tumors allowed patient characteristics: age * 18 to 70 performance status * who 0-1 life expectancy * not specified hematopoietic * neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * ast no greater than 1.5 times upper limit of normal (uln) * alkaline phosphatase no greater than 2.5 times uln * bilirubin no greater than 1.5 times uln renal * creatinine clearance greater than 60 ml/min cardiovascular * no new york heart association class iii or iv congestive heart failure * no unstable angina pectoris * no myocardial infarction within the past 3 months * no significant arrhythmias * no other severe or uncontrolled cardiovascular disease other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 12 months after study treatment * no definite contraindications to corticosteroids as premedication * no geographic situation that would preclude proper staging and follow-up * no active uncontrolled infection * no preexisting peripheral neuropathy greater than grade 1 * no uncontrolled diabetes mellitus * no active autoimmune disease * no other serious medical condition that would preclude study participation * no other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix * no significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy endocrine therapy * not specified radiotherapy * no prior radiotherapy to the chest surgery * not specified other * more than 30 days since prior treatment on another clinical trial * no other concurrent experimental drugs

Keywords: stage ii esophageal cancer stage iii esophageal cancer adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus